Nurse Intervention Project

Not Applicable

Completed

• Conditions: Breast Cancer Patients
• Interventions: Device: distress thermometer

• Registration Number: NCT01091584
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. There is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the Netherlands. A task force discussed and studied which instrument measures psychosocial problems best. The distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the Netherlands. However, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-24
• Primary Completion: 2013-02
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

Inclusion Criteria

• Histologically proven malignancy of the breast
• Curative treatment
• Dominated the dutch language
• Age > 18 year

Exclusion Criteria

• Previously treated for a malignancy
• Psychiatric problems that adherence this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	distress thermometer	The intervention is to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse.

Primary Outcome Measures

Name	Time	Method
Subscale quality of life of the questionnaire: EORTC QLQ C30	After each treatment completion, during follow up; first year every 3 months, second year every 6 months	Subscale quality of life of the questionnaire: EORTC QLQ C30

Secondary Outcome Measures

Name	Time	Method
Other subscales	After each treatment completion, during follow up; first year every 3 months, second year every 6 months	Other subscales: * HADS : anxiety and depression; * EORTC BR23 : breast cancer specific problems; * SVL: Impact of Event Scale; * ZCL : illness cognition questionnaire with subscales: disease benefits, acceptance and helplessness; * EuroQoL6D,; * Cost diary

Trial Locations

Locations (1)

University Medical Centre Nijmegen; 🇳🇱 Nijmegen, Netherlands